Your Partners in Success

As your trusted partner, ECI provides strategic consulting and service solutions for the life sciences industry. Lean on our diverse perspectives and decades of experience to tackle your toughest challenges within your dynamic field.

What to Expect During an FDA Inspection and How to Prepare

Learn how to prepare and what to expect from the FDA during an inspection in the medical device industry.

Expansion of FDA's Authority to Regulate Cosmetics

On December 23, 2022, Congress enacted the first major change to the FDA’s ability to regulate cosmetics since the Food Drug & Cosmetic Act.

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Proven Solutions for Your Regulatory, Quality & Engineering Needs

At ECI, our expert team has assisted a broad range of companies solve an even broader range of challenges, from full product lifecycle management, regulatory strategy, and post market surveillance to successful remediation and beyond. We’re here to help you identify pain points in your processes and meet them with effective solutions as we chart the best path forward together. 

WHY ECi?
97%

client retention rate

285

projects managed within the last three years

100+

consultants ready to support each project

Industries We Serve

We understand the complexity and ever-changing nature of the regulatory landscape. Our consultants possess the in-depth expertise required to navigate the distinct compliance requirements within various industry sectors under the life sciences domain. This ensures that, even when challenges arise, you can proceed with unwavering confidence.

Medical Devices

Biotech

Pharmaceutical

Nutritionals & Dietary Supplements

Cosmetics

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Our Strategic Solutions

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Impact That’s Tangible

Why not experience the value ECI delivers to a myriad of clients firsthand? Explore our collection of case studies to gain insights into the challenges our customers have encountered. Delve into project objectives, actions, strategies employed, and the resulting outcomes for each.

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Quality Management System Remediation

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Mock FDA Audit

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Design File History Integration via Acquisition

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EU MDR Regulatory Submissions

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Regulatory Strategy

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Warning Letter: Regulatory Responsibility

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When You Succeed, We Succeed.

The quality of the work we do builds trust and sets the stage for long-term, effective relationships. See what ECI customers are saying about working with us.

"What an amazing accomplishment! Thank you to the team and all who supported this effort! To pull this in as far as you did is outstanding! This will ensure submission of the product early next year and finish the last submission. Awesome job everyone. "
Project Manager
"I cannot say enough great things about the ECI consultants. They are doing absolutely great work and adding a ton of value!"
Director, Global Product Marketing
"I would like to thank you all for being the leaders this program needs, exhibiting many elements of the company’s recognized 4 pillars of Leadership: Strategic, Collaborative, People, Performance."
R&D Manager
"This submission will ensure the product remains available to our patients for years to come. The team displayed continuous cross-functional collaboration, adaptability, and constant focus to achieve an on-time submission. Thank you to each team member for your hard work, and countless hours of dedication to achieve this great goal of submitting for EUMDR approval."
R&D Project Manager
“I am pleased to wholeheartedly recommend ECI consultants for their outstanding collaboration during our quality system implementation and remediation, audit preparation and readiness, as well as their pivotal role in our multi-site support endeavors across both the US and Europe. Their comprehensive regulatory knowledge, strategic insights, and meticulous audit groundwork have been integral to our achievement of compliance and enhanced credibility.”
Sr. Manager, Global Quality Systems
"This is a moment to reflect and thank you for your contribution to our integration’s core system and distribution 'go live' project and for the extra effort you put in day in and day out to ensure a smooth transition. Your creativity and willingness to collaborate continuously set a high bar within the project team.”
Sr. Technical Writer
"I give my full endorsement to the key attributes that ECI will bring to your organization. Specifically, their knowledge, professionalism, drive, quality of work and eagerness to do things right the first time will add value to your impending project needs. Brijesh and Shital were the project lead on multiple devices ranging from urology to endoscopy; all work has passed multiple audits in the years since."
Sr. Process Development Engineer
"ECI has helped our company create key quality system policies and procedures. The ECI management is very collaborative, engaging, and responsive to our needs. They ensured that the work was managed effectively and efficiently."
VP of Corporate Quality
"Based on their experience, ECI recommended placing on-site managers to assist with activities and personnel, which eased the added strain on our full-time managers due to the number of contracted resources. I would not hesitate to use ECI for future projects; I found their professionalism and depth of resources was second to none. We succeeded in completing our mission and owe a great deal of the success to Enhanced Compliance."
Director, Engineering & Product Development
“ECI was contracted to support a large remediation project. Thanks to Randy providing onsite project management, the additional quality system resources needed to address the issues were quickly defined. ECI was able to deploy many highly qualified consultants as requested. The entire ECI team was professional, collaborative, and hard-working. The regulatory resources provided positive contributions on day one, given their valuable skillsets such as software development, engineering experience and a former FDA reviewer.”
Sr. Director of Regulatory Affairs
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Our People

Relationships matter, and when you choose to do business with a corporation, you’re choosing to do business with the people who make it up. Our team at ECI promises to work hard to help our clients achieve compliance for their products, but more than that, to build lasting relationships through mutual respect and trust. Join the Team.

Let’s Collaborate

Whether you have an issue that requires immediate response or you’re looking for a partner equipped to help improve your processes long-term, let us help you address your market challenges. We would welcome the opportunity to support you.

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